Mechanical prostheses: old and new.

Cardiovascular clinics Pub Date : 1993-01-01
R B Karp, M E Sand
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Abstract

The four mechanical valve prostheses currently available on the U.S. market have evolved from a field of more than 50 valves produced for human implantation since the early 1950s (Tables 11-1 to 11-4). This literature establishes that good results can be achieved with a number of cardiac prostheses if properly used and monitored after implant. The current generation of valves have demonstrated ease of implantation, improved durability, good hemodynamic performance, and reduced thromboembolism and thrombosis with proper anticoagulation. The cost and complexity of completing PMA by the FDA, concern over product liability, and patent rights on design and raw materials have narrowed the choice of devices for surgeons in the United States and slowed the pace of new market entries. The evolution of mechanical valves has been reviewed and modes of valve failure reviewed when pertinent. Clinical expectations for earlier generation devices and present valves also are reviewed. Prostheses under evaluation are discussed along with considerations for valve implantation, surveillance, and anticoagulation. We have employed the SJM valve since about 1985. The proven good hemodynamic performance in small sizes and low profile have made its application well suited to the pediatric population and for smaller aortic roots. The well-guarded hinge mechanism and low probability for disc entrapment have facilitated its use in chordal sparing mitral replacements in our experience. Application in the tricuspid position also has been successful but requires close attention to anticoagulation.

机械假体:新旧。
自20世纪50年代初以来,已生产了50多种用于人体植入的瓣膜,目前美国市场上有四种机械瓣膜(表11-1至11-4)。本文献表明,如果正确使用并在植入后进行监测,许多心脏假体都可以取得良好的效果。当前一代的瓣膜已经证明易于植入,提高耐用性,良好的血流动力学性能,并通过适当的抗凝治疗减少血栓栓塞和血栓形成。完成FDA PMA的成本和复杂性,对产品责任的担忧,以及设计和原材料的专利权,已经缩小了美国外科医生的设备选择范围,减缓了新市场进入的步伐。回顾了机械阀门的发展历程,并在适当的时候回顾了阀门失效的模式。对早期设备和当前瓣膜的临床期望也进行了回顾。在评估假体,并考虑瓣膜植入,监测和抗凝。我们从1985年开始使用SJM阀门。经证实,小尺寸和低轮廓的良好血流动力学性能使其应用于儿科人群和较小的主动脉根部。根据我们的经验,良好的保护铰链机制和低概率的椎间盘夹持促进了它在保留脊索的二尖瓣置换术中的应用。在三尖瓣位置的应用也取得了成功,但需要密切注意抗凝。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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